NCT02112370

Efficacy of Ropivacaine (With Epinephrine) in BABA Endoscopic and Robotic Thyroidectomy

Phase 3 Study of Ropivacaine (With Epinephrine) in BABA Endoscopic and Robotic Thyroidectomy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

To assess the pain relief and the hemodynamic stability of ropivacaine with epinephrine in BABA endoscopic and robotic thyroidectomy.

Detailed description

Diluted ropivacaine with epinephrine is injected into the subcutaneous space to relieve pain and reduce bleeding during procedures. The synergistic effect of ropivacaine with epinephrine can contribute to patients' welfare, such as relieving pain and structuring the hemodynamic stability.

Conditions

• Thyroid Neoplasm
• Goiter

Interventions

Type	Name	Description
DRUG	Ropivacaine with epinephrine injection	1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection for the experiment group.
OTHER	Placebo	100cc normal saline is injected into the subcutaneous layer for the initial flap dissection for the placebo group.

Timeline

• Start date: 2014-05-01
• Primary completion: 2016-05-01
• Completion: 2016-06-01
• First posted: 2014-04-11
• Last updated: 2017-08-04
• Results posted: 2017-08-04

Locations

2 sites across 1 country: South Korea